David Goldberg, M.D., M.S.C.E., associate professor of medicine in the Division of Digestive Health and Liver Diseases at the University of Miami Miller School of Medicine, is one of three principal investigators of a five-year, $7.8 million National Institutes of Health-funded study using donor kidneys infected with hepatitis C (HCV) in patients awaiting kidney transplants who do not have HCV.
The University of Miami/Jackson Memorial Hospital will be one of eight U.S. clinical sites performing kidney transplants with donor kidneys infected with HCV, then treating patients with an oral antiviral medication to cure the HCV.
Dr. Goldberg and colleagues began investigating the possibility that HCV-infected organs could safely offer an alternative to people awaiting kidney and other organ transplants while he was with the Perelman School of Medicine at the University of Pennsylvania. He continues that work today with the Miller School, collaborating with co-principal investigators from Penn, Peter Reese, M.D., M.S.C.E., associate professor of medicine, and Douglas Schaubel, Ph.D., professor of biostatistics.
“In 2015, my colleagues at Penn and I published a perspective piece in the New England Journal of Medicine about the potential to transplant kidneys from donors infected with hepatitis C into people without hepatitis C,” he said. “In 2017, we were the first to publish our data in the New England Journal of Medicine about our experience in doing 10 of these transplants.”
Kidney transplant outcomes were successful in this and other trials, and the practice of using HCV-infected organs for transplant and then treating transplant patients with medicine to cure HCV grew, with some institutions continuing to do studies and others using it as a standard practice.
The problem, according to Dr. Goldberg, was that the practice was outpacing the science. There were no standard protocols; many scientific questions about how to achieve best results were unanswered; and insurance companies continue to delay or deny coverage in many cases for the medication because treating patients acutely infected with HCV is considered off label.
“This trial of 400 patients and 200 transplants will help to standardize the practice of using HCV-infected organs, answer those questions and hopefully make this option accessible and recognized as safe and something to be covered without delay by insurance,” he said.
The Miller School will begin recruiting patients awaiting kidney transplants in South Florida for the trial this summer. While NIH is funding the trial, Gilead Sciences, maker of the FDA-approved HCV treatment Sofosbuvir/Velpatasvir (Epclusa), is providing the medication free of charge to study participants.
As of April 13, the day NIH announced the grant had been awarded, 1,465 people were on a kidney transplant waiting list in South Florida, including Miami-Dade, Broward, Palm Beach, and Collier counties. The pandemic could further increase the need for donor kidneys. Scientists have found that patients in the intensive care unit with COVID-19 are at increased risk for heart, lung, and/or kidney damage and some will need heart, lung, and/or kidney transplants.
“It could also be that ICU patients with COVID-19 and prolonged kidney failure will need transplants in the future,” Dr. Goldberg said.
Using HCV-infected organs to transplant in HCV-free patients awaiting organs would not have been possible when Dr. Goldberg completed his fellowship training in hepatology 10 years ago.
“Back then, hepatitis C was a dreaded disease and difficult to treat,” he said. “Now we are doing a clinical trial that allows us to transplant patients with a kidney from a donor infected with hepatitis C and provide treatment with a greater than 95% cure rate as a way to transplant them earlier and get them off dialysis faster.”
The NIH funding for the trial will go through the Miller School’s Department of Medicine. Miller School co-investigators are Javier Pagan, M.D., associate professor in the Division of Nephrology and Hypertension; Eric F. Martin, M.D., of the UM/Jackson Miami Transplant Institute; and Michele Morris, M.D., professor of clinical medicine at the Miller School. Patients will receive their transplant surgeries at the Miami Transplant Institute.
Johns Hopkins, Massachusetts General Hospital, New York Presbyterian Hospital/Columbia University, University of Cincinnati, Washington University, and Vanderbilt University also are clinical sites participating in the NIH-funded study.
More information about the trial is available at ClinicalTrials.gov.